510(k) · Cleared
ClearedClareon and Solarus Pulsed Light Devices and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novalis Medical, LLC · GEX Powered Laser Surgical Instrument
Cleared on Dec 17, 2004 as substantially equivalent to K020453 (Palomar Medical Technologies, Inc., 2002) and 5 other predicates after a 15-day review. Its family tree reaches back 6 generations to 1992. 15 later devices descend from it.
- Decided
- Dec 17, 2004
- Review
- 15 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 6 generations to K910422 (1992). 55 ancestors in all, the oldest K892514 (1990). 15 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 5 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 4 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 3 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 2 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 1 generation backK020453 Palomar Estelux Pulsed Light System and Palomar CoolrollerPalomar Medical Technologies, Inc. · 2002
- This deviceK043319 Clareon and Solarus Pulsed Light Devices and AccessoriesNovalis Medical, LLC · 2004
- Descendant · cites it directly · 8 of its ownK051508 Med Flash II Intense Pulsed Light System.General Project S.R.L. · 2005
- Descendant · 2 generations on · 6 of its ownK072331 Radiancy Mistral DeviceRadiancy (Israel), Ltd. · 2008
- Descendant · 3 generations on · 4 of its ownK091664 GSD Intense Pulsed Light System, Models: GP666C4, GP666CShenzhen Gsd Tech Co., Ltd. · 2009
- Descendant · cites it directly · 4 of its ownK062048 Aesthera Photopneumatic (PPX) SystemAesthera Corporation · 2006
- Descendant · 2 generations on · 3 of its ownK083730 IsolazAesthera Corporation · 2009
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K051508Med Flash II Intense Pulsed Light System.General Project S.R.L. · 2005 · cites it directly8descendants
- K072331Radiancy Mistral DeviceRadiancy (Israel), Ltd. · 2008 · 2 generations on6descendants
- K091664GSD Intense Pulsed Light System, Models: GP666C4, GP666CShenzhen Gsd Tech Co., Ltd. · 2009 · 3 generations on4descendants
- K062048Aesthera Photopneumatic (PPX) SystemAesthera Corporation · 2006 · cites it directly4descendants
- K083730IsolazAesthera Corporation · 2009 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −5 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −4 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −3 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −2 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −1 | K020453 | Palomar Estelux Pulsed Light System and Palomar Coolroller | Palomar Medical Technologies, Inc. | 2002 | — |
| 0 (this device) | K043319 | Clareon and Solarus Pulsed Light Devices and Accessories | Novalis Medical, LLC | 2004 | — |
| +1 | K051508 | Med Flash II Intense Pulsed Light System. | General Project S.R.L. | 2005 | — |
| +2 | K072331 | Radiancy Mistral Device | Radiancy (Israel), Ltd. | 2008 | — |
| +3 | K091664 | GSD Intense Pulsed Light System, Models: GP666C4, GP666C | Shenzhen Gsd Tech Co., Ltd. | 2009 | — |
| +1 | K062048 | Aesthera Photopneumatic (PPX) System | Aesthera Corporation | 2006 | — |
| +2 | K083730 | Isolaz | Aesthera Corporation | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 7 | 0 |
| 1995 | 6 | 0 |
| 1996 | 7 | 0 |
| 1997 | 6 | 0 |
| 1998 | 5 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K020453 | Palomar Estelux Pulsed Light System and Palomar CoolrollerSummary page 1…Product Code: GEX Legally marketed predicate Device(s): Palomar Medical Technologies, Inc. EsteLux TM (K020453), LuxVTM Handpiece (K040081) and LuxGTM Handpiece… | 2002 |
| * | K040081 | Palomar Luxv HandpieceSummary page 1…ce(s): Palomar Medical Technologies, Inc. EsteLux TM (K020453), LuxVTM Handpiece (K040081) and LuxGTM Handpiece (K020941) Lumenis (form… | 2004 |
| * | K020941 | Palomar Luxg HandpieceSummary page 1…EsteLux TM (K020453), LuxVTM Handpiece (K040081) and LuxGTM Handpiece (K020941) Lumenis (formerly ESC) EpiLightTm (K963249)… | 2002 |
| * | K963249 | Epilight Hair Removal SystemSummary page 1…(K020941) Lumenis (formerly ESC) EpiLightTm (K963249) and Lumenis Family of IPL Systems { Specifically the Quantum SR… | 1997 |
| * | K020839 | Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLSummary page 1…(K963249) and Lumenis Family of IPL Systems { Specifically the Quantum SR model} (K020839) Radiancy Radiancy Acne System with ClearTouc… | 2002 |
| * | K032205 | Radiancy Acne System with Cleartouch Light Unit AssemblySummary page 1…model} (K020839) Radiancy Radiancy Acne System with ClearTouch LUA (K032205) System Description: The ClareonTM and Solar… | 2003 |
What descends from it? (15)
See all 153 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 55 ancestors has a recall of any class.
- Of its descendants, K051508 (General Project S.R.L., 2005) has gone furthest, with 8 descendants of its own.
- 14 other devices also cite its predicate K020453.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
The ClareonTM and Solarus TM Pulsed Light Systems are light-based medical device(s) intended for use with the following:
HR Handpiece - Permanent hair reduction.
AR Handpiece - Treatment of inflammatory acne.
VR Handpiece - Photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels(facial and leg veins), and treatment of benign pigmented lesions.
SR Handoiece - Photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels(facial and leg veins), and treatment of benign pigmented lesions. Removal of unwanted hair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043319 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043319: Clareon and Solarus Pulsed Light Devices and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043319
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026